Description

Berotralstat CAS NO 1809010-50-1 is a potent and selective small molecule inhibitor of plasma kallikrein, representing a significant advancement in targeted therapeutic agents. This compound is critical for the development of novel treatments for hereditary angioedema (HAE) and other conditions mediated by the kallikrein-kinin system. Pharmaceutical research and development organizations, as well as advanced fine chemical manufacturers, require this high-purity intermediate for preclinical studies, formulation development, and clinical trial material production.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Key building block in the synthesis of the final Berotralstat drug substance.
• Preclinical & Clinical Research: Used in pharmacological studies, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and as a reference standard in bioanalytical method development.
• Hereditary Angioedema (HAE) Therapeutics: Central to R&D programs focused on developing prophylactic treatments for HAE attacks.
• Process Chemistry & Scale-Up: Serves as a critical intermediate for process optimization, route scouting, and manufacturing scale-up activities.
• Biochemical Assay Development: Utilized as a specific inhibitor to study the role of plasma kallikrein in various inflammatory and vascular pathways.
• Reference Standard: Provides a high-purity compound for quality control, method validation, and regulatory submissions.

Basic Information

Item	Detail
Product Name	Berotralstat
CAS No.	1809010-50-1
Molecular Formula	C23H22F3N5O3
Molecular Weight	473.45 g/mol
Synonyms	BCX7353; Orladeyo (Brand Name); (R)-N-((3-(3-(4-(2,2,2-Trifluoroethoxy)phenyl)propanoyl)-1H-indazol-5-yl)methyl)-1-methyl-1H-pyrazole-5-carboxamide; 1-Methyl-N-[[(5R)-3-[3-[4-(2,2,2-trifluoroethoxy)phenyl]-1-oxopropyl]-1H-indazol-5-yl]methyl]-1H-pyrazole-5-carboxamide; Plasma Kallikrein Inhibitor BCX-7353; Berotralstat diastereomer
EINECS	Contact for details

Quality Control

Our Berotralstat is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical development. A Certificate of Analysis (COA) is provided with each shipment, detailing specifications such as assay, chiral purity, and impurity profiles. We support development with regulatory starting material (RSM) documentation as needed.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0% (R-enantiomer)
Related Substances (HPLC)	Total impurities ≤2.0%; Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤1.0%
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.